Alternative Cancer Research Model Accelerates Studies, Improves Cost Benefits

05/24/18

A review published in Cancer (online May 14, 2018; doi: 10.1002/cncr.31522) proposes a new form of research that includes cancer researchers as the primary drivers of the process and outlines the benefits of the model in relation to potential improved cost benefits.

Pharmaceutical manufacturers have employed Contract Research Organizations (CROs) since the 1980s to design guidelines with often rigorous patient eligibility criteria. Current clinical trial methodology may limit patient access to and eligibility for studies, slow down the drug development process, and increase costs.

Hagop M Kantarjian, MD, department of leukemia, The University of Texas MD Anderson Cancer Center, and colleagues conducted an assessment of an alternative research model for improving clinical trial development by including academic cancer experts and pharmaceutical manufacturers. The model was piloted in a multi-study leukemia research program supported by MD Anderson and Bristol-Myers Squibb. The model is designed to allow researchers to come to data conclusions more quickly, to conduct multiple trials of novel therapies across several cancer types, and to lessen overall expenses.

The collaboration has led to simultaneous trials using combinations—triplets in some cases—for chronic lymphocytic leukemia, acute myeloid leukemia, chronic myeloid leukemia (CML), and myelodysplastic syndrome. As a result, a new standard of care has been established for the treatment of CML that includes an altered dose of dasatinib.

Furthermore, the collaboration has allowed MD Anderson leukemia researchers to explore Bristol-Myers Squibb’s immune-oncology pipeline across multiple blood malignancies, provides high-risk patients access to trials that they would not typically have due to CRO restrictions, and grants funding for all trials led by MD Anderson research programs with Bristol-Myers Squibb without having to negotiate on a trial-by-trial basis.

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"This cancer research model is flexible and modifiable according to existing needs because it does not pretend to create a 'one-size-fits-all' approach," Dr Kantarjian said in a press release (May 14, 2018). "These types of alliances have significant variations that accommodate the partnering drug company - its drug pipeline, research needs, financial benefits and other considerations."—Zachary Bessette